Methods, devices, systems, assemblies, and kits for tissue retraction in an oral cavity

ABSTRACT

Provided herein is a retraction device for retracting soft tissue from the dental surfaces in the oral cavity of a patient. The retraction device is comprised of a topology conformable structure, where the topology conformable structure is adaptable to be delivered to the oral cavity in a constrained shape. The device can then undergo a conformation change in the oral cavity, where the device transforms into its unconstrained shape. The unconstrained shape of the device creates a useable working field in the oral cavity. The useable working field can provide increased accessibility to and/or visibility within the oral cavity. Also provided herein are methods for using the device and kits.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/166,011, filed May 26, 2016, which is a continuation of U.S. patentapplication Ser. No. 13/829,609, filed Mar. 14, 2013, which is acontinuation of U.S. patent application Ser. No. 12/239,477, filed Sep.26, 2008, now abandoned, which claims the benefit of U.S. ProvisionalApplication No. 60/975,387, filed Sep. 26, 2007, U.S. ProvisionalApplication No. 61/026,989, filed Feb. 7, 2008, and U.S. ProvisionalApplication No. 61/081,908, filed Jul. 18, 2008, the disclosures ofwhich are incorporated herein in their entirety.

BACKGROUND OF THE INVENTION

The mouth or oral cavity 10 of a human is illustrated in FIG. 1A toprovide context for the invention. The mouth, or oral cavity, is boundedby muscles and bones: anteriorly by the lips 12, posteriorly continuouswith the oropharynx, laterally by the muscles of the cheeks 14,superiorly by the body hard palate and muscular soft palate 16; andinferiorly by the muscular tongue 18 and the soft tissues of the floorof the mouth. The tongue is a voluntary muscular structure that occupiesthe floor of the mouth. Teeth 20 are embedded in the alveoli or socketsof alveolar ridges of the mandible 30 which forms a mandibular arch 32,or alveolar process, which contain the lower (caudad) set of teeth andmaxilla 40 which forms a maxillary arch 42, or alveolar process, whichcontains the upper (cephalad) set of teeth. Each of the alveolar arch32, 42, has an external surface 34, 44 which is adjacent the checks andlips and an internal surface 36, 46 adjacent the tongue and palate. Theteeth 20 engage the gingival tissue 22.

The mouth 10 has salivary glands that secrete about 1.5 L of fluid dailyinto the mouth. Secretion of saliva is controlled by the autonomicnervous system. Parasympathetic stimulation causes vasodilation andsecretion of water saliva with low enzyme content, whereas sympatheticstimulation cases vasoconstriction and secretion of smaller amounts ofsaliva that are richer in organic materials. Reflex secretion occurswhen, for example, there is food in the mouth.

Devices and systems currently known and used in the dental arts includethose disclosed in: U.S. Pat. No. 4,695,253 to Tysse for Oral EvacuationDevice and Method; U.S. Pat. No. 6,981,870 to Heasley for Rubber DamClamps Retained by Adhesion and Improved Frictional Forces; U.S. Pat.No. 6,022,214 to Hirsch et al. for Intraoral Illumination Device andMethod of Using Same; U.S. Pat. No. 5,931,673 to Bobolan for IntraoralDental Dam; U.S. Pat. No. 5,890,899 to Sclafani for Dental Isolator;U.S. Pat. No. 5,516,286 to Kushner for Dental Isolation TrayParticularly Suited for Use When Applying Dental Sealants and Method forIts Use; U.S. Pat. No. 5,460,524 to Anderson for Device and Method forSaliva Suction with Tongue Retractor and Bit Handle; U.S. Pat. No.5,078,604 to Malmin for Dental Barrier Drape Devices and RetainerApparatus Therefor; U.S. Pat. No. 5,037,298 to Hickham for Apparatus andImproves Process for Removing Saliva While Retracting Cheeks and Lips;U.S. Pat. No. 4,899,490 to Jenkinson for Dental Mask; U.S. Pat. No.4,215,477 to Shanel for Holder for Rubber Dental Dam; U.S. Pat. No.3,772,790 to Swan-Gett et al. for Tooth Isolating Shield; U.S. PatentPublication US 2004/0170945 to Heasley for General Field IsolationRubber Dams without Operative Inserts Which Isolate the Dental AlveolarArch for Dental Treatment; and US 2007/0231773 to Pontynen et al. forMethods, Devices, Systems, and Kits for Isolating Teeth.

Commercially available devices include, for example, Isolite i2 byIsolyte Systems (Santa Barbara, Calif.), described atwww.isolitesystems.com; OptiDam by KerrHawe SA (Switzerland), describedat www.kerrhawe.com; and OptraGate and OptraDam by IvoClar Vivident Ltd.(New Zealand), described at www.ivoclar.co.nz.

It would be beneficial to have a device, system, assembly, kit andmethod that enables dental practitioners to quickly retract tissue andisolate one or more teeth and/or gingival tissue in the oral cavity fromsurrounding tissue to generate a working field and which maintains a dryworking field for performing the dental procedure.

SUMMARY OF THE INVENTION

Provided herein is a retraction device comprising a topology conformablestructure adaptable to be in a constrained shape that can be deliveredinto an oral cavity and further adaptable to be in an unconstrainedshape to create a useable working field in the oral cavity, the useableworking field providing increased accessibility and increased visibilitywithin the oral cavity. In some embodiments, the conformable structureis a frame. Additionally, the frame can further comprise a membrane. Theframe can also comprise a light source. The frame can also comprise anevacuation component. The device can be adaptable to be deployed inunder 1 minute. In some embodiments, the device can be adaptable tocreate a working field in under 1 minute. The device can be deployed inunder 20 seconds. The device can further comprise a tongue retractorwherein the tongue retractor can be adaptable to deflect the tonguewithout passing over either arch of teeth. The tongue retractor cancontain and confine the tongue in a restricted space. In someembodiments, the device can further comprise at least one evacuationcomponent. The evacuation component can be used to remove saliva orother bodily fluids from the oral cavity. Additionally, the evacuationcomponent can be used to remove moist air or breath from the oralcavity. The device can be adaptable to retract soft tissue surroundingat least one arch of teeth. Additionally, the device can be adaptable toretract the soft tissue surrounding both the upper and lower arches ofteeth in the oral cavity. The device can also be used in some cases toisolate at least a portion of gum tissue in the oral cavity. Inisolating the teeth of gum tissue, the device can be used to create abarrier that can be efficiently separate dental surfaces from anyinfluence by saliva or other body fluids. Furthermore, the device cancomprise at least one aperture to facilitate the ability to breathethrough the device. The device can facilitate the scanning of the dentalsurfaces by providing increased accessibility to the oral cavity andincreased visibility within the structures within the oral cavity. Thedevice can facilitate scanning or imaging of the oral cavity, whereinthe scanning or imaging comprises at least one of digitalscanning/imaging or optical scanning/imaging. Furthermore, the devicecan be adaptable to isolate both arches of teeth is less then 20seconds. In some embodiments, the device can be adaptable to bepositioned without interfering with access to dental surfaces, whilealso being further adaptable to prevent interference with access todental surfaces by the tongue, cheeks or lips and further adaptable toprovide maximum patient comfort.

Further provided herein is a retraction device comprising a topologyconformable structure adaptable to create a working field in an oralcavity of a patient, wherein the working field is at least 10% largerthan a working field created in the oral cavity of the patient withoutuse of the device. The device can be used to provide at least 10% moreaccess to an area of interest in the oral cavity. In some embodiments,the area of interest is one arch of teeth. Alternatively, the area ofinterest can be both arches of teeth. The device can be adaptable toprovide at least 10% more visibility within the oral cavity. The devicecan be adaptable to provide at least 10% less contamination ofstructures located in the oral cavity by fluid. The fluid can be saliva,blood, or any other suitable bodily fluid. In some embodiments, thedevice can be adaptable to provide at least 10% less interference bysoft tissue in accessing structures in the oral cavity. The conformablestructure can be a frame. The device can be adaptable to evacuate bodilyfluids from a protected side of the oral cavity and also any fluid usedto rinse the oral cavity on the working field side of the membraneduring a procedure. In some embodiments, the device can comprise a fullmembrane that can isolate the oral cavity from harmful debris orundesirable chemicals and tastes. In some embodiments, the frame is awire frame. In some embodiments, the device further comprises amembrane. Additionally, the device can comprise a light source. Thelight source can be used to illuminate the oral cavity. The light sourcecan be used to cure materials placed in the oral cavity. Alternatively,the device can comprise light sources that can either illuminate or curematerial. The device can be adaptable to isolate at least one archlocated within the oral cavity or create a barrier that can efficientlyseparate dental surfaces from any influence by saliva or other bodilyfluid. The device can be adaptable to isolate the upper arch and thelower arch in the oral cavity. In some embodiments, the device can beadaptable to isolate at least a portion of gum tissue in the oralcavity. The device can be used to isolate the entire gum tissue.Furthermore, the device can be adaptable to be deployed in under 1minute. The device can also be adaptable to create a working field inunder 1 minute. In some embodiments, the device can be deployed in under20 seconds. Additionally, no further adjustment of the device can beneeded after the device has been deployed. In some embodiments, thedevice can further comprise a tongue retractor. The tongue retractor cancontain and confine the tongue in a restricted space. The tongueretractor and the elements which attach it to the rest of the device canbe adaptable to allow a first occlusal surface of a tooth in the upperarch of teeth and a second occlusal surface of a tooth in the lower archof teeth to touch. The tongue retractor can be adaptable to compress atleast one side of the tongue or both sides of the tongue. The device canbe adaptable to apply suction to the oral cavity. The device can beadaptable to apply suction to the oral cavity through at least oneaperture. The device can also be adaptable to facilitate the ability tobreathe through the device. The device can be adaptable to isolate atleast one dental arch or create a barrier around the at least one dentalarch in less than 20 seconds. The device can further be adaptable to bepositioned without interfering with access to dental surfaces andfurther adaptable to provide maximum patient comfort.

Additionally, provided herein is a retraction device comprising amalleable frame adaptable to be in a constrained shape that can bedelivered into an oral cavity and further adaptable to be in anunconstrained shape to isolate at least one arch of teeth from salivaand soft tissue surrounding the arch. The malleable frame can be a wireframe, including but not limited to a metal wire. Alternatively, thewire frame can be a polymer frame or a combination or metal and polymerframe. The malleable frame can further comprise a membrane.Additionally, the device can further comprise a light source. In someembodiments, the device can be adaptable to be deployed in under 1minute, the device can be adaptable to be deployed in under 20 seconds,in some embodiments. The device can also be adaptable to create aworking field in under 1 minute. Furthermore, the device can comprise atongue retractor. The tongue retractor can contain and confine thetongue. The tongue retractor and the elements which attach it to therest of the device can be adaptable to allow a first occlusal surface ofa tooth in the upper arch of teeth and a second occlusal surface in thelower arch of teeth to touch. The device can also comprise at least oneevacuation component. The device can be adaptable to retract soft tissuesurrounding at least one arch of teeth or in some cases, retract thesoft tissue surrounding the upper and lower arches of teeth. The devicecan be adaptable to isolate at least a portion of gum tissue located inthe oral cavity. In some embodiments, the device further comprises atleast one aperture to facilitate the ability to breathe through at leastone aperture in the device. The device can be further adaptable tofacilitate the application of a substance to at least one tooth surface.The substance can be a powder. In some embodiments, the powder is areflective powder. The powder can be an imaging powder for pattering thedental surfaces. The substance can be a dental restorative material ormedication. The device can also be adaptable to facilitate theapplication of hardware (orthodontic brackets) to at least one toothsurface. The device can be further adaptable to facilitate treatment ofat least one periodontal pocket using including, but not limited to, alaser device, an ultrasonic or sonic frequency scaler device, treatmentwith hand scalers and curettes, periodontal surgery, or dental implantplacement, or any suitable combination thereof. The device can also beadaptable to isolate at least one dental arch in less than 20 seconds.The device can be adaptable to create a working field withoutinterfering with access to dental surfaces. The device can be furtheradaptable to be positioned in the mouth to provide for maximum patientcomfort.

Further provided herein are methods of use of the invention describedherein. Provided herein is a method of retracting tissue in an oralcavity comprising: inserting a retraction device comprising a topologyconformable structure adaptable to be in a constrained shape that can bedelivered into an oral cavity and further adaptable to be in anunconstrained shape to create a useable working field in the oralcavity, the useable working field providing increased accessibility toand increased visibility within the oral cavity; and positioning theretraction device in the oral cavity to create the useable workingfield. The positioning step can be performed in less than 1 minute. Insome embodiments, the positioning step can be performed in less than 20seconds.

Yet another method for retracting tissue in an oral cavity comprises:inserting a retraction device comprising a topology conformablestructure adaptable to create a useable working field in an oral cavityof a patient, wherein the working field is at least 10% larger than aworking field in oral cavity of the patient without use of the device;and positioning the retraction device in the oral cavity to create theworking field.

Another method provided herein is a method of facilitating the creationof an oral cavity model comprising: inserting a retraction devicecomprising a topology conformable structure adaptable to be in aconstrained shape that can be delivered into an oral cavity and furtheradaptable to be in an unconstrained shape to create a useable workingfield in the oral cavity, the usable working field providing increasedaccessibility to and increased visibility within the oral cavity; andpositioning the retraction device in the oral cavity to create theuseable working field in the oral cavity. In some embodiments, themethod can further comprise the step of illuminating the oral cavitywith the retraction device. Additionally, the method can comprise thestep of applying an imaging powder to the at least one dry toothsurface.

Further provided herein are kits for retracting tissue in an oralcavity. Provided herein are kits for retracting tissue in an oral cavitycomprising: a topology conformable structure adaptable to be in aconstrained shape that can be delivered into an oral cavity and furtheradaptable to be in an unconstrained shape to create a useable workingfield in the oral cavity, the useable working field providing increasedaccessibility to and increased visibility within the oral cavity. Insome embodiments, the kit can further comprise a tongue retractor.Additionally, the kit can further comprise a light ring. Furthermore,the kit can comprise an evacuation component. The kit can furthercomprise a membrane adaptable to be fitted over the frame. In someembodiments, the kit can further comprise a gum protection cover. Thekit can also further comprise a lip ring.

Furthermore, additionally provided herein is a kit for retracting tissuein an oral cavity comprising: a retraction device comprising a topologyconformable structure adaptable to be in a constrained shape that can bedelivered into an oral cavity and further adaptable to be in anunconstrained shape to create a useable working field in the oralcavity, the useable working field providing increased accessibility toand increased visibility within the oral cavity; and a kit of secondarydental products wherein tissue retraction in the oral cavity isnecessary. In some embodiments, the kit can further comprise anillumination source. Additionally, the kit can comprise at least oneoptical scanner or digital scanner. Furthermore, the kit can furthercomprise a powder for facilitate scanning of the dental surfaces. Insome embodiments, the kit can further comprise a whitening or bleachingkit.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A depicts an anterior view of an oral cavity with the mouth openand the teeth exposed illustrating the structures of the oral cavity;FIG. 1B is an illustration of a human body with the anatomical planes ofthe body identified;

FIGS. 2A-2E illustrate one embodiment of a retraction device positionedin the oral cavity of a patient; FIG. 2A is a perspective view of thedevice positioned in the oral cavity; FIG. 2B is a side view of theretraction device positioned within the oral cavity; FIG. 2C depicts aportion of the retraction device positioned over the caudad portion ofthe oral cavity as viewed along the line B-B in FIG. 2B;

FIG. 2D depicts a portion of the retraction device positioned over thecaudad portion of the oral cavity as viewed along the line B-B in FIG.2B, without surrounding tissue structures; FIG. 2E depicts a portion ofthe retraction device positioned over the cephalad portion of the oralcavity as viewed along the line B-B in FIG. 2B; FIG. 2F depicts ananterior view of the device positioned in the oral cavity; FIG. 2Gdepicts a cross-sectional view of the device, and surrounding tissuestructures, along the sagittal plane;

FIGS. 3A-3D illustrate one embodiment of a retraction device; FIG. 3A isperspective view of the retraction device as viewed from the distal endof the device; FIG. 3B is a top view of the retraction device; FIG. 3cis a side view of retraction device; FIG. 3D is a posterior view of theretraction device;

FIGS. 4A-4D illustrate the tongue and gum protection cover isolated fromthe retraction device;

FIG. 4A is a perspective view of the tongue and gum protection cover ofthe retraction device as viewed from the distal end of the device; FIG.4B is a top view of the tongue and gum protection cover of theretraction device; FIG. 4C is a side view of the tongue and gumprotection cover of the retraction device;

FIG. 4D is a posterior view of the tongue and gum protection cover ofthe retraction device;

FIGS. 5A-5D illustrate the frame covering both the upper and lowerarches of the retraction device, isolated from the membrane of theretraction device; FIG. 5A is a perspective view of the frame as viewedfrom the distal end of the device; FIG. 5B is a top view of the frame ofthe retraction device;

FIG. 5C is a side view of the frame of the retraction device; FIG. 5D isa posterior view of the frame of the retraction device;

FIGS. 6A-6D illustrate the light ring portion of the retraction deviceisolated from the retraction device; FIG. 6A illustrates a perspectiveview of the light ring as viewed from the posterior side; FIG. 6Billustrates a top view of the light ring; FIG. 6C illustrates a sideview of the isolated light ring; FIG. 6D illustrates a posterior view ofthe light ring;

FIGS. 7A-7D illustrate an alternative embodiment of a retraction devicewithout a tongue or gum protection component; FIG. 7A illustrates theretraction device as viewed from the distal end of the device; FIG. 7Billustrates a top view of the retraction device; FIG. 7C illustrates aside view of the retraction device; FIG. 7D illustrates a posterior viewof the retraction device;

FIGS. 8A-8D illustrate an alternative embodiments of a retraction devicehaving a frame covered by a membrane; FIG. 8A illustrates a perspectiveview of the isolation/retraction device; FIG. 8B illustrates a top viewof the isolation/retraction device; FIG. 8C illustrates a side view ofthe isolation/retraction device; FIG. 8D illustrates a posterior view ofthe isolation/retraction device;

FIGS. 9A-9D illustrate the isolation membrane or cover of the retractiondevice isolated from the retraction device; FIG. 9A illustrates aperspective view of the isolation membrane of the retraction device;FIG. 9B illustrates a top view of the isolation membrane of theretraction device; FIG. 9C illustrates a side view of the isolationmembrane/cover of the retraction device; FIG. 9D illustrates a posteriorview of the isolation membrane/cover of the retraction device;

FIGS. 10A-10D illustrate an alternative embodiment of a light ring andlip and cheek retractor isolated from a retraction device; FIG. 10Aillustrates a perspective view of the light ring; FIG. 10B illustrates atop view of the isolated light ring; FIG. 10C illustrates a side view ofthe isolated light ring;

FIG. 10D illustrates a posterior view of the isolated light ring;

FIGS. 11A-11D illustrate an alternate embodiment of a light ringcomprising a flexible electrical circuit membrane; FIG. 11A illustratesa perspective view of the light ring; FIG. 11B illustrates a top view ofthe isolated light ring; FIG. 11C illustrates a side view of theisolated light ring; FIG. 11D illustrates a posterior view of theisolated light ring;

FIGS. 12A-12D illustrate an alternate embodiment of an isolated frame ofa retraction device, including tongue cover, and lip and cheekretraction ring; FIG. 12A illustrates a perspective view of the frame;FIG. 12B illustrates a top view of an isolated frame; FIG. 12Cillustrates a side view of an isolated frame; FIG. 12D illustrates aposterior view of the isolated frame;

FIGS. 13A-13D illustrate an alternate embodiment of an isolated frame ofa retraction device; FIG. 13A illustrates a perspective view of theframe; FIG. 13B illustrates a top view of an isolated frame of theretraction device; FIG. 13C illustrates a side of the frame; FIG. 13Dillustrates a posterior view of the isolated frame;

FIGS. 14A-14D illustrate an isolated view an alternative embodiment of aframe; FIG. 14A illustrates a perspective view of the frame; FIG. 14Billustrates a top view of the frame; FIG. 14C illustrates a side view ofthe frame; FIG. 14D illustrates an posterior view of the frame;

FIGS. 15A-15D illustrate an alternate embodiment of a frame comprisingan evacuation component; FIG. 15S illustrates a perspective view of theframe; FIG. 15B illustrates a top view of the frame; FIG. 15Cillustrates a side view of the frame; FIG. 15D illustrates an posteriorview of the frame;

FIGS. 16A-16D illustrate an alternative embodiment of an isolated lipring; FIG. 16A illustrates a perspective view of the lip ring as viewedfrom the distal side; FIG. 16B illustrates a top view of the lip ring;FIG. 16C illustrates a side view of the lip ring; FIG. 16D illustrates aposterior view of the lip ring;

FIGS. 17A-17D illustrate an embodiment of an isolated tongue cover; FIG.17A illustrates a perspective view of the tongue cover; FIG. 17Billustrates a top view of a tongue cover; FIG. 17C illustrates a sideview of a tongue cover; FIG. 17D illustrates a posterior view of atongue cover;

FIGS. 18A-18D illustrates an alternate embodiment of an frame adaptableto be folded; FIG. 18A illustrates a perspective view of the frame asviewed from the distal end; FIG. 18B illustrates a top view of theframe; FIG. 18C illustrates a side view of the frame; FIG. 18Dillustrates a posterior view of the frame;

FIGS. 19A-19D illustrates an alternative embodiment of a foldable framewithout a tongue cover; FIG. 19A illustrates a perspective view of theframe as viewed from the distal end; FIG. 19B illustrates a top view ofthe frame; FIG. 19C illustrates a side view of the frame; FIG. 19Dillustrates a posterior view of the frame;

FIGS. 20A-20D illustrate isolated cheek retractors from a foldableframe; FIG. 20A illustrates a perspective view of the cheek retractors;FIG. 20B illustrates a top view of the cheek retractors; FIG. 20Cillustrates a side view of the cheek retractors; FIG. 20D illustrates aposterior view of the cheek retractors;

FIGS. 21A-21D illustrate a retraction device for retracting tissuesurrounding the lower arch, tongue, cheeks, and lips, including lightingand suction; FIG. 21A illustrates a perspective view of the retractiondevice as viewed from the distal side; FIG. 21B illustrates theretraction device as viewed from top; FIG. 21C illustrates a side viewof the retraction device; FIG. 21D illustrates a posterior view of theretraction device;

FIGS. 22A-22D illustrates an alternative embodiment of a retractiondevice comprising a frame with gum protector and tongue cover; FIG. 22Aillustrates a perspective view of the retraction device as viewed fromthe distal side; FIG. 22B illustrates a top view of the retractiondevice; FIG. 22C illustrates a side view of a retraction device; FIG.22D illustrates a posterior view of a retraction device;

FIGS. 23A-23D illustrate an alternative embodiment of a membraneisolated from the retraction device comprising a gum protector, a tonguecover and evacuation component; FIG. 23A illustrates a perspective viewof the retraction device as viewed from the distal end; FIG. 23Billustrates a top view of the retraction device; FIG. 23C illustrates aside view of the retraction device; FIG. 23D illustrates a posteriorview of the retraction device;

FIGS. 24A-24D illustrate an isolated view of an alternate embodiment ofa frame comprising an evacuation component; FIG. 24A illustrates aperspective view of the frame as viewed from the distal end; FIG. 24Billustrates a top view of the frame; FIG. 24C illustrates a side view ofthe frame; FIG. 24D illustrates a posterior view of the frame;

FIGS. 25A-25D illustrate an alternate embodiment of a retraction devicecomprising a lower frame and gum protector and light lip ring; FIG. 25Aillustrates a perspective view of the retraction device as viewed fromthe distal end; FIG. 25B illustrates a top view of the frame; FIG. 25Cillustrates a side view of the frame; FIG. 25D illustrates a posteriorview of the frame;

FIGS. 26A-26D illustrate an alternate embodiment of a retraction devicecomprising a lower arch frame and a tongue cover; FIG. 26A illustrates aperspective view of the retraction device; FIG. 26B illustrates a topview of the retraction device; FIG. 26C illustrates a side view of theretraction device; FIG. 26D illustrates a posterior view of theretraction device;

FIGS. 27A-27D illustrates an alternative embodiment of retraction devicecomprising an upper and lower arch frame and tongue cover; FIG. 27A is aperspective view of the frame as viewed from the front; FIG. 27Billustrates a top view of the retraction device; FIG. 27C illustrates aside view of the retraction device; FIG. 27D illustrates a view of theretraction device as viewed from the top;

FIGS. 28A-28D illustrate an alternate embodiment of an isolated framecomprising a evacuation component; FIG. 28A illustrates a perspectiveview of the frame as viewed from the distal side; FIG. 28B illustrates atop view of the frame; FIG. 28C illustrates a side view of the frame;FIG. 28D illustrates a posterior view of the frame;

FIGS. 29A-29D illustrate an isolated tongue cover; FIG. 29A illustratesa perspective view of the tongue cover as viewed from the distal side;FIG. 28B illustrates a top view of the tongue cover; FIG. 29Cillustrates a side view of the tongue cover; FIG. 29D illustrates aposterior view of the tongue cover;

FIGS. 30A-30D illustrates an isolated upper arch frame; FIG. 30Aillustrates a perspective view of the frame; FIG. 30B illustrates a topview of frame; FIG. 30C illustrates a side view of the frame; FIG. 30Dillustrates a posterior view of the frame;

FIGS. 31A-31D illustrates an alternative embodiment of an isolated upperand lower arch frame; FIG. 31A illustrates a perspective view of theframe; FIG. 31B illustrates a top view of frame; FIG. 31C illustrates aside view of the frame; FIG. 31D illustrates a frontal view of theframe; and

FIGS. 32A-32D illustrates an alternative embodiment of a retractiondevice frame; FIG. 32A illustrates a perspective view of the frame; FIG.32B illustrates a top view of frame; FIG. 32C illustrates a side view ofthe frame; FIG. 32D illustrates a frontal view of the frame.

DETAILED DESCRIPTION OF THE INVENTION

In order to understand the configurability, adaptability and operationalaspects of the invention, it is helpful to understand the anatomicalreferences of the body 50 with respect to which the position andoperation of the device, and components thereof, are described. Thereare three anatomical planes generally used in anatomy to describe thehuman body and structure within the human body: the axial plane 52, thesagittal plane 54 and the coronal plane 56 (see FIG. 1B). Additionally,devices and the operation of devices are better understood with respectto the caudad 60 direction and/or the cephalad direction 62. Devicespositioned within the body can be positioned dorsally 73, e.g., at aposterior side or end 70, such that the placement or operation of thedevice is toward the back or rear of the body. Alternatively, devicescan be positioned ventrally 71, e.g., at an anterior side or end 72,such that the placement or operation of the device is toward the frontof the body. Various embodiments of the device for isolating teeth,systems and kits of the present invention may be configurable andvariable with respect to a single anatomical plane or with respect totwo or more anatomic. Similarly, the various components can incorporatediffering sizes and/or shapes in order to accommodate differing patientoral cavity sizes.

Provided herein is a retraction device for isolating the lower and upperarches of teeth located in the oral cavity. The retraction device canisolate the lower and upper arches of teeth. Additionally, theretraction device can isolate gum tissue located adjacent to the lowerand upper arches. By isolating the dental surfaces, the device can beused to create a barrier that can efficiently separate the dentalsurfaces from any influence by saliva or other body fluids. A portion ofthe gum tissue can be isolated or the entire gum tissue can be isolated.The present invention contemplates devices adapted and configured toretract tissue in the oral cavity away from one or more dental arches orfrom one or more teeth. By retracting the tissue, teeth are set apart orkept away from other tissue, saliva, and debris to create a site withinthe oral cavity suitable to perform a dental procedure, such as dentalimaging. As will be appreciated by those skilled in the art, because theteeth are embedded in the jaw bone, a target tooth is not per se“isolated” from a neighboring tooth. However, the devices, can beconfigured such that the target tooth is isolated from a neighboringtooth such that the neighboring tooth is not impacted by the use ofdental materials during a procedure on the target tooth. Isolation ofone or more target teeth can also include exposing those teeth to createa surgical sit, or site for performing a procedure. Isolation of one ormore target teeth can also include creating a barrier that canefficiently separate dental surfaces from any influence by saliva orother body fluids.

The devices are further configured such that they are rapidlydeployable. The devices are able to quickly achieve a dry working fieldand substantially maintain the working field condition during theprocedure without the need for interaction. The device can isolate atleast one arch of teeth in seconds. In some embodiments, the device canbe deployed to isolate the upper and lower arches of teeth in less thanabout 60 seconds or 1 minute. In some embodiments, the device can bedeployed to isolate the upper and lower arches of teeth in less thanabout 1 minute. In some embodiments, the device can be deployed toisolate the upper and lower arches of teeth in less than about 20seconds.

In some embodiments, a device of the present invention is a single unitapparatus that can be positioned within a patient's mouth to isolate oneor more of the patient's teeth by retracting tissue, including thetongue. The ability to retract the tongue provides considerableadvantage for accessing the oral cavity. For example, a device can be asingle arch that isolates only the upper teeth or a portion thereof or asingle arch that isolates only the lower teeth or a portion thereof.Such single-arch devices which isolate only lower or upper teeth can beused independently or in combination with one another to form a twopiece device. In some embodiments, a single arch (e.g., lower arch)device is coupled to a paddle that isolates the other half of the mouthand tongue (e.g., the upper teeth) and/or keeps the mouth open. Sincethe device herein is shaped like the mouth, the device can be insertedinto a patient's mouth accurately in about one minute or less or about20 seconds or less.

The devices herein include one or more retractors. A retractor is anelement that deflects, retracts, or displaces soft tissue, such as lips,tongue and/or cheek(s), away from teeth and/or alveolar surfaces. Insome embodiments, a device comprises one retractor. In some embodiments,a device comprises two retractors. The tongue can be deflected by anopen tongue retractor structure, such as a wire tongue retractor.Alternatively, the tongue retractor can include a cover for containingthe tongue from the sides. The tongue can be entirely confined withinthe tongue retractor so that the tongue is confined within a restrictedspace and thereby prevented from filling the oral cavity. Additionalretractors can be used, especially when each retractor uniquely retractsa different portion of the cheek(s) and/or lip(s).

Devices can further be adapted and configured to provide one or moreapertures that correspond with one or more upper and/or lower teeth. Alower retractor may be provided adjacent an aperture for the lower teethsuch that it is adapted and configured to extend or protrude the lowerlip and cheeks away from the lower teeth, or at least a target lowertooth, e.g. where only one tooth is exposed through the lower toothaperture. Similarly, an upper retractor may be positioned adjacent anaperture corresponding to one or more upper teeth, wherein the retractoris adapted and configured to extend or protrude the upper lip and cheeksaway from the upper teeth, or at least a target upper tooth. The upperand/or lower teeth can be inserted into such tooth receiving apertureswithout impinging on the patient's teeth and without forceful contactwith the alveolar process or gingiva. In some embodiments, additionalregions of interest (e.g., gums) may be exposed by using a more minimaldevice or by removing (such as by cutting) one or more parts of thedevice as necessary.

The retractor can have various dimensions to achieve suitable to achievecreation of a working field around a target tooth or teeth. Thus, thelength, height, curvature (including the radius of curvature), and widthcan be adjusted to take into account the size of the mouth and/or thefacial features of the patient. For example, in some embodiments,retractors can be configured to increase in size as the retractorextends away from the alveolar arch to allow for retraction of morecheek muscle. In some embodiments, a lower retractor and/or an upperretractor is between about 1 mm to about 10 cm in height. Retractors forchildren, adults, and animals can have different lengths, widths,curvatures, including the frame elements having varying radii ofcurvature, etc.

The lower and upper retractors can be adapted to extend to the back ofthe mouth where the retractors interconnect. For example, the lower andupper retractors may be connected on both the right and left back(posterior) sides of the mouth, e.g. immediately posterior the mostposteriorly positioned tooth, via a flexible bridge that permits thepatient to open and close their mouth with the device fully deployedtherein. Such a bridge can include, for example, one or more featuresadapted to increase flexibility or rigidity. In some embodiments, thebridges comprise folds, bellows or ribs which increase its elasticity.In some devices, the bridges are made of a different material than theretractors. Additionally, the lower and upper retractors can beconnected via an inflexible bridge forcing a patient to keep their mouthopen at a specified angle. In some embodiments, the bridges are designedto help keep a patient's mouth open but also provide flexibility topermit closing of the mouth.

A flange or bridge (such as “webbing”) can also be provided thatconnects the anterior portion of the lower retractor prevents the tonguefrom dislodging the device by positioning the tongue over the top of thewebbed portion described.

The bridges in the back of the mouth can be coupled to or extend into ashield that prevents debris and other components from entering thethroat during a dental procedure. The shield can have a proximalcurvature to allow extra room for the tongue. In some embodiments, theshield curvature is such that the apex of curvature is in the center ofthe mouth. In some embodiments, the shield can further act as a tonguecontainment device, tongue retractor, tongue deflector, tonguesuppressor, tongue elevator, tongue support, etc. In some embodiments,the shield comprises an aperture or apertures (mesh) in its center topermit a patient to breathe using their mouth. The aperture allows thepatient to breath through the mouth. Additionally, the aperture may belarge enough such that the patient can put their tongue into and/orthrough the aperture. The aperture can also be used to provide access tothe back of the mouth e.g. to visualize debris or saliva build-up, aswell as to give access to high volume suction.

Some configurations of the shield are configured to function as a tongueretractor comprises a surface that is a u-shaped flange extending fromthe inside of the mouth toward the outside. The bottom surface of thetongue retractor can have an internal surface with side surfacesextending from top to bottom forming a barrier between the mouth and thethroat. The throat barrier is below the breathing aperture, whichpermits the patient to breathe through the mouth during the procedure.

In some embodiments, a shield can be used to maintain the patient'smouth in an open state. Such shield has a support mechanism above thebreathing cavity. The support mechanism may be a u-shaped flange thatextends upwardly and externally above the breathing cavity. The supportmechanism is adapted to maintain the mouth cavity open. The supportmechanism is especially useful for dental surgery, when the patient isunconscious or sedated.

Devices of the invention can also be adapted and configured to integratewith a saliva ejection or suction/evacuation element. A saliva suctionelement includes, for example, one or more suction inlets, one or moresuction channels, and one or more suction outlets. A suction channel canextend from a region inside the mouth (e.g. posteriorly and then forwardin and around the alveolar process under the tongue) to a region near orat the mouth opening (e.g. anteriorly). A suction channel can beintegrated into the frame of the device. For example, a suction inletcan be at a region abutting the internal cheek or back of the mouth whenthe device is deployed. In some embodiment multiple suction inlets alignthe bottom lower retractors. Such suction inlets are coupled to a singlechannel leading to an outlet or port in the front of the patient'smouth. A suction channel can extend from the suction inlet within theframe of the device, or external to the device, to a suction outlet orport located at the proximal end of the device herein or proximal to thedevice herein (external to the mouth). The suction port can be coupledto a suction device external to the patient to draw saliva from the backof the mouth outside the patient. A saliva ejection or suction elementenhances the seal around the teeth. In some embodiments, suctionchannels(s) and outlet(s) are located on the underside (meaning the“tissue side”) of the “sealing mechanism” such that the device attachesitself firmly to the alveolar process or upper and lower alveolarprocesses when suction is applied. The suction actuated sealingmechanism can also consists of a suction channel within the “windshieldwiper blade” or retractor element, with perforations positioned in tworows on the tissue side (“underside”) of the seal. In the case of theupper arch portion of the device, the perforations are on the superiorsurface of the seal. When suction is applied to the channel or channels,via a port or ports near the proximal end of the device, the seal(s)adhere(s) to the alveolar process or processes. The suction is alsocapable of evacuating saliva on the tissue side of the barrier whileevacuating debris and other contaminates on the working field side ofthe barrier.

The devices herein can also be integrated with a lighting element. Aswith other components of the invention, the integrated light can beformed integrally, such that it is a constituent piece of the device, orsuch that the device ultimately forms a single unit, one component ofwhich is the light fixture. Such devices are composed of a translucentmaterial capable of illuminating once it is inserted into the patient'smouth. In some embodiments, the device comprises LED light source or afiber optic light source, or an effervescent light source either ofwhich can, for example, be embedded in the device or coated on thedevice. The lighting device can also be configured such that it ispowered by an external power source or a power source that is notexternal. Light sources can be located along the sides of the device, oralong the top or the device or along the bottom of the device or allover the device.

The devices herein can be manufactured using an elastic but somewhatstiff wire to form the upper and lower retractors. The wire can beencapsulated in silicone and then encapsulated by a soft polymericmaterial, for example. In some embodiments, the wire is a polymer wire.Alternatively, the wire can be a metal wire. In some embodiments, thewire is used by itself without a soft membrane or coating. In someembodiments, a nickel/titanium alloy wire is used for the frame tooptimize the collapsibility of the device for insertion purposes andcompliance with mouth shape while providing the forces necessary toaccomplish retraction of cheeks and tongue and to position the sealingmechanism. The heat in the oral cavity can activate property changes inthe metal springing it into its designed shape making it less intrusiveto insert. In some embodiments, a nylon or other plastic material isused for this “wire frame” that may be effected by the body heat also.

The devices described herein are particularly useful in aiding theimaging or scanning of the dental surfaces located within the oralcavity. The device can be used to create a larger working field, whereinthe working field comprises the dental surfaces of interest and the areasurrounding the dental surfaces of interest. The devices describedherein can be used to create a larger working field to facilitateimaging the oral cavity. The oral cavity can be imaged using radiologyequipment, such as X-rays, or to scan the dental surfaces by enabling abetter insertion of the scanning device into the oral cavity.Additionally, the larger working field, together with the dry dentalsurfaces created by the devices, further facilitate the scanning of thedental surfaces by allowing for the placement of a powder on the dentalsurfaces, wherein the power aids in the ability to scan the dentalsurfaces. The devices can also be used to facilitate the generation ofdental impressions by ensuring proper placement of dental trays withinin the oral cavity since the devices can embody a design with minimalmaterial, thereby taking up less space in the oral cavity. This providesfor less interference by both the devices and the soft tissue with thematerials and kits needed to create the dental tray. The ability to makea dental impression, utilizing the established, well controlled, fullarch working field provided by the device provides a major advantage tothe dentist. The dentist can transition directly from proceduresinvolving the teeth or periodontal structures to making an impression ofthe area or an entire arch of teeth without removing the device or evercompromising the working field required for a complete and accurateimpression.

The remainder of the devices herein can be made from one or morepolymeric materials including, but not limited, to c-Flex-thermalplastic elastomer (TPE), silicon, slow recovery foam (SRF), andpolypropylene (PP). Preferably, a clear polymer is used to manufacturethe devices herein. The material can be embossed or pre-molded into theshape of the inside of the mouth which provides extra comfort to thepatient. The device can be composed of one or more materials or of asingle material having two or more durometers. In one embodiment, afirst material conforms to the shape of the alveolar process(es) andcreates a seal around one or more of the teeth while the second materialprovides a structure that retracts the cheek(s) and tongue, providing aclear working field for the dental practitioner and comfort and safetyfor the patient. In any of the embodiments herein, a material canoptionally contain a lubricant or flavored lubricant to facilitateinsertion and removal. In some embodiments, the device is molded in thepractitioner's office to fit the individual patient. In someembodiments, a practitioner can measure a patient's mouth, using asterilizable and reusable “tri-in” device, as an aid in selecting thebest size of device for the patient. Overall, the device herein can bemade in different sizes to fit different size mouths. In someembodiments, a device herein can be used in veterinary dentalprocedures. Such devices can be adapted to fit an animal being treated(e.g., dog, cat, horse, etc.). The sealing portion of the device can beformed from any suitable hydrophilic material, hydrophobic material, ora putty (e.g., Van-R reversible hydrocolloid, available from Dux Dental,and vinyl polysiloxane, available from 3M Express).

Prior to inserting the devices described herein into a patient's mouth,the devices have a circular circumference as provided by the upper andlower retractors. The devices can have at least one, two, or threeapertures—e.g., one for one or more of the lower teeth, and/or one forone or more of the upper teeth, and/or one for the tongue and/or airwayand/or the largest (proximal or posteriorly positioned) aperture whichis used for access to the working field. The apertures for the targetteeth (either upper or lower) can be formed by implanting the device andpunching one or more target teeth through a perforated ridge. In someembodiments, a first aperture is designed to expose/isolate all of thetarget teeth and is c-shaped; a second aperture is designed toexpose/isolate all of the target teeth. The first and second aperturesborder on their exterior end with retractors adapted to retract the lipsand cheeks away from all teeth. The upper and lower retractors arecoupled in the back of the mouth using flexible bridges that permit thepatient to open their mouth at various angles. The bridges are alsocoupled to a shield with an aperture large enough to allow at least aportion of the patient's tongue to protrude through it.

As will be appreciated by those skilled in the art, the devices can beadapted and configured to completely isolate both full arches of teethand is adapted to permit closing of the mouth. This may allow the upperand lower teeth to come together and permits a dental practitioner tomake a judgment about the interaction(s) of upper and lower teeth (e.g.,bite). The ability to look at all arch of teeth also permits judgmentbased on features of other teeth whether they are being worked on or not(e.g., comparing teeth coloration, etc.). Furthermore, exposing aplurality of teeth permits a dental practitioner to work on more than 1,2, 3, 4, 5, 6 etc., teeth each of which may be located in a differentpart of the mouth without having to re-adjust the device.

The devices are adapted and configured for use in a procedure requiringa dry environment, such as performing restoration (e.g., crown andfilling work) or creating molds of the oral cavity. Absence of salivacan impact the quality of a tooth impression, especially when makingimpressions of teeth prepared for laboratory fabricated dentalrestorations or prostheses. The devices of this invention enable apractitioner to insert the device, optionally perform suction on anysaliva that remains in the patient's mouth or perform any other step tofacilitate a dry working field, and then insert impression material ontoa tooth, remove that impression material and optionally insert a fillingmaterial. The devices permit an impression to be taken and filling addedwithout removing the device so that no impression or filling materialgoes down the patient's throat. The devices also helps prevent salivafrom getting onto the teeth during the entire period it is placed in themouth.

For surgical procedures, the devices can be used to isolate one or moreteeth of interest while preventing blood, disposables, implantableparts, implanted related parts, or instruments from getting into thepatient's throat. The device can be used to create a barrier that canefficiently prevent inhalation or ingestion of

The retraction devices described herein can comprise a topologyconformable structure adaptable to be in a constrained shape that can bedelivered into an oral cavity and further adaptable to be in anunconstrained shape to create a useable working field in the oralcavity, the useable working field providing increased accessibility toand increased visibility within the oral cavity. In some embodiments,the conformable structure is a frame. Additionally, the frame canfurther comprise a membrane. The frame can also comprise a light source.The device can be adaptable to be deployed in under 1 minute. In someembodiments, the device can be adaptable to create a working field inunder 1 minute. The device can be deployed in under 20 seconds. Thedevice can further comprise a tongue retractor wherein the tongueretractor can be adaptable to deflect the tongue without passing overeither arch of teeth. The tongue retractor can contain and confine thetongue in a restricted space. In some embodiments, the device canfurther comprise at least one evacuation element. The device can beadaptable to retract soft tissue surrounding at least one arch of teeth.Additionally, the device can be adaptable to retract the upper and lowerarches of teeth in the oral cavity. The device can also be used in somecases to isolate at least a portion of gum tissue in the oral cavity.Furthermore, the device can comprise at least one aperture to facilitatethe ability to breathe through the device. The device can facilitate thescanning of the dental surfaces wherein the scanning comprises at leastone of digital scanning or optical scanning. Furthermore, the device canbe adaptable to isolate both arches of teeth is less than 20 seconds. Insome embodiments, the device can be adaptable to be positioned withoutinterfering with access to dental surfaces and further adaptable toprovide maximum patient comfort.

Further provided herein is a retraction device comprising a topologyconformable structure adaptable to create a working field in an oralcavity of a patient, wherein the working field is at least 10% largerthan a working field created in the oral cavity of the patient withoutuse of the device. The device can be used to provide at least 10% moreaccess to an area of interest in the oral cavity. In some embodiments,the area of interest is one arch of teeth. Alternatively, the area ofinterest can be both arches of teeth. The device can be adaptable toprovide at least 10% more visibility within the oral cavity. The devicecan be adaptable to provide at least 10% less contamination ofstructures located in the oral cavity by fluid. The fluid can be saliva,blood, or any other bodily fluid. In some embodiments, the device can beadaptable to provide at least 10% less interference between soft tissueand instruments accessing the oral cavity. The conformable structure canbe a frame. In some embodiments, the frame is a wire frame. In someembodiments, the device further comprises a membrane. Additionally, thedevice can comprise a light source. The device can be adaptable toisolate at least one arch located within the oral cavity. The device canbe adaptable to isolate the upper arch and the lower arch in the oralcavity. In some embodiments, the device can be adaptable to isolate atleast a portion of gum tissue in the oral cavity. The device can be usedto isolate the entire gum tissue. Furthermore, the device can beadaptable to be deployed in under 1 minute. The device can also beadaptable to create a working field in under 1 minute. In someembodiments, the device can be deployed in under 20 seconds.Additionally, no further adjustment of the device can be needed afterthe device has been deployed. In some embodiments, the device canfurther comprise a tongue retractor. The tongue retractor can containand confine the tongue in a restricted space. The tongue retractor canbe adaptable to allow a first occlusal surface and a second occlusalsurface to touch. The tongue retractor can be adaptable to compress atleast one side of the tongue or both sides of the tongue. The device canbe adaptable to apply suction to the oral cavity. The device can be usedto evacuate the oral cavity. The device can be adaptable to applysuction to the oral cavity through at least one aperture adaptable tofacilitate the ability to breathe through the device. The device can beadaptable to isolate at least one dental arch in less than 20 seconds.The device can further be adaptable to be positioned without interferingwith access to dental surfaces and further adaptable to provide maximumpatient comfort.

Additionally, provided herein is a retraction device comprising amalleable frame adaptable to be in a constrained shape that can bedelivered into an oral cavity and further adaptable to be in anunconstrained shape to isolate at least one arch of teeth from salivaand soft tissue surrounding the arch. The malleable frame can be a wireframe. The malleable frame can further comprise a membrane.Additionally, the device can further comprise a light source. In someembodiments, the device can be adaptable to be deployed in under 1minute. The device can be adaptable to be deployed in under 20 seconds,in some embodiments. The device can also be adaptable to create aworking field in under 1 minute. Furthermore, the device can comprise atongue retractor. The tongue retractor can contain and confine thetongue. The tongue retractor can be adaptable to allow a first occlusalsurface and a second occlusal surface to touch. The device can alsocomprise at least one evacuation element. The device can be adaptable toretract soft tissue surrounding at least one arch of teeth or in somecases, retract the soft tissue surrounding the upper and lower arches ofteeth. The device can be adaptable to isolate at least a portion of gumtissue located in the oral cavity. In some embodiments, the devicefurther comprises at least one aperture to facilitate the ability tobreathe through the device. The device can be further adaptable tofacilitate the application of a substance to at least one tooth surface.The substance can be a powder. In some embodiments, the power is areflective powder. The powder can help create a pattering on the surfacethe teeth. The device can also be adaptable to isolate at least onedental arch in less than 20 seconds. The device can be adaptable tocreate a working field without interfering with access to dentalsurfaces. The device can be further adaptable to be positioned in themouth to provide for maximum patient comfort.

As described above, FIG. 1A depicts an oral cavity 10 from an anterior72 view with the mouth 10 open and the teeth exposed 20 and FIG. 1Billustrates a human body with the anatomical planes of the bodyidentified.

I. Devices

FIG. 2A illustrates a perspective view of one embodiment of a retractiondevice 200, as viewed from the front and at an above angle as positionedwithin the oral cavity 10. The device 200 can comprise a cheek or softtissue retraction frame 202 having an anterior end 72 and a posteriorend 70. The device can further comprise a lip ring 208 for retracting atleast one lip. Additionally, the device can comprise an evacuationcomponent capable of suctioning fluid from the oral cavity. Theevacuation component can be in communication, preferably fluidcommunication, with the oral cavity 10 through at least one inlet 212 inthe frame 202. FIG. 2B is a side view of the device 200 as positionedwithin the oral cavity 10. The frame can be comprised of an upper frame204 having a first end 205 and a second end 205′ and a lower frame 206having a first end 207 and a second end 207′, and wherein respectivefirst ends 205, 207 and second ends 205′, 207′ are connected via a crossmember 240. In some embodiments, inlets 212 for evacuating the oralcavity 10 can be located in the upper frame 204 and the lower frame 202.FIG. 2B also illustrates how the lip ring 208 can be used to retract thelips 12, 12′. In some embodiments, the device can further comprise atongue retractor 210 having an elongated structure with an upper end anda lower end when viewed from a sagital plane perspective, a curved shapewhen viewed from a coronal plane perspective, and a surface between saidupper and lower ends to limit forward movement of a tongue toward apatient's teeth. FIG. 2C illustrates a cross-sectional view of the oralcavity along the line B-B in FIG. 2B. FIG. 2C is a cross sectional viewof the caudal side of the oral cavity. FIG. 2C illustrates thepositioning of the upper frame 204 of the device 200 around the gums ofthe upper dental arch 42, retracting the cheek tissue 14 away from thegums. FIG. 2C also illustrates how the upper portion of the lip ring 208can retract the upper lip 12. FIG. 2D illustrates the complete frameviewed from the top of the device in position around the upper dentalarch and the upper portion of the lip ring 208 without any surroundingsoft tissue. The gum protection cover 220 is covering the upper frame inFIG. 2D. FIG. 2E illustrates a cross-sectional view of the oral cavityalong the line B-B in FIG. 2B, viewing the cephalic portion of the oralcavity. FIG. 2E illustrates how the lower frame 206 of the deviceisolates the gums of the lower dental arch from the cheeks tissue 14′.FIG. 2E also illustrates the retraction of the lower lip 12′ by the lipring 208. FIG. 2E also shows inlets 212 in the frame for evacuatingfluid from the oral cavity. FIG. 2F illustrates a frontal view of thedevice 200 in position in the oral cavity 10. FIG. 2F illustrates theupper frame 204 and the lower frame 206 and a lip ring 208. The lowerframe 206 has inlets 212 for providing suction. FIG. 2F also illustratesa device 200 with a tongue retractor 210 as viewed from the front. FIG.2G illustrates a cross-sectional view of the device 200 shown in FIG. 2Galong the line C-C.

FIGS. 3A-3D illustrates one embodiment of an isolated retraction device.FIG. 3A illustrates a perspective view of the device as viewed from thedistal end of the device 300, wherein the device has an anterior end 72and a posterior end 70 positionable distally in the oral cavity. FIG. 3Aillustrates an upper frame 304 having a first end 305 and a second end305′, a lower frame 306 having a first end 307 and a second end 307′,wherein respective first ends 305, 307 and second ends 305′, 307′ areconnected via a cross member 340, and a lip ring 308. The lower framecomprises inlets 312 for evacuating the oral cavity. FIG. 3A alsoillustrates a device 300 comprising a lip ring 308 further comprising alight ring 314. The device in FIG. 3A also comprises a tongue retractor310 having an elongated structure with an upper end and a lower end whenviewed from a sagital plane perspective, a curved shape when viewed froma coronal plane perspective, and a surface between said upper and lowerends to limit forward movement of a tongue toward a patient's teeth.FIG. 3B is a top view of the retraction device 300. FIG. 3B illustratesthe upper frame with gum protection cover 320, the top portion of thelip ring 308, and the light sources 316, 316′ for providing light to thelight ring portion of the lip ring 308. The light source can either beisolated power sources for light, such as self-contained batteries, oralternatively, the light sources can be connectors which can be used toplug in an external power source. The light ring can be used toilluminate the oral cavity. The light ring can comprise any suitablefeature for generating light to illuminate the oral cavity including,but not limited to, light emitting diodes (LEDs), fiber optic wires,light bulbs, fluorescent or chemiluminescent light sources, or any othersuitable light source. The light sources 316, 316′ can be connected toan external power supply. Alternatively, the light sources can comprisebatteries. FIG. 3C illustrates a side view of the isolated retractiondevice 300. In addition to the upper frame 304, the lower frame 306, thetongue retractor 310, lip ring 308, light ring 314, and light sources316, the device 300 can further comprise a lip rest 318 for providingfurther retraction of the lip and to facilitate placement of the device.FIG. 3D illustrates a posterior view of the device 300 illustrating theupper frame 304 with gum protection cover 320, the lower frame 306 withgum protection cover 320, portions of the lip ring 308, and theposterior side of the tongue retractor 310.

FIGS. 4A-4D illustrate the upper gum protection cover 420 and the lowergum protection cover 422 isolated from the retraction device, whereinthe device has an anterior end 72, a posterior end 70, and a crossmember 440. FIG. 4A is a perspective view of the gum protection covers420, 422, and the tongue retractor 410 having an elongated structurewith an upper end and a lower end when viewed from a sagital planeperspective, a curved shape when viewed from a coronal planeperspective, and a surface between said upper and lower ends to limitforward movement of a tongue toward a patient's teeth. Inlet 412 can beseen in the lower gum protection cover 422. The inlets 412 can providecommunication, preferably fluid communication, between the oral cavityand the retraction device. The upper and lower gum protection covers canbe rigid. Alternatively, the gum protectors can be soft, pliablemembranes. The gum protectors can be made out any suitable materialincluding, but not limited to, rubber, wax, foam, or any other suitablematerial or combination thereof FIG. 4B is a top view of a retractiondevice 400, illustrating the upper gum protector 420 and the tongueretractor 410. FIG. 4C illustrates a side view of the gum protectioncovers, both the upper gum protection cover 420 and the lower gumprotection cover 422. FIG. 4C also shows the tongue retractor 410. FIG.4D illustrates a posterior view of the retraction device 400,illustrating the upper gum protection cover 420 and the lower gumprotection cover 422. Inlets 412 for evacuating the oral cavity can beseen in the lower gum protection cover 422.

In some embodiments, the retraction device 500 is comprised of a frame502, as shown in FIGS. 5A-5D. The frame 502 can be further comprised ofan upper frame 504 having a first end 505 and a second end 505′ and alower frame 506 having a first end 507 and a second end 507′, whereinrespective first ends 505, 507 and second ends 505′, 507′ are connectedvia a cross member 540. The frame can be a malleable frame. It can beshaped to conform to the topology of the patient's oral cavity. In someembodiments, the frame is a wire frame. In some embodiments, the frameis made of a moldable plastic or wax. The frame can be made out of anysuitable material for making the frame. Inlets 512 for evacuating theoral cavity can be seen in the lower frame 506. A suction port locatedon the bottom frame 524 can be used to introduce suction through theinlets 512 in the lower frame 506. FIG. 5A also illustrates a tongueretractor 510 having an elongated structure with an upper end and alower end when viewed from a sagital plane perspective, a curved shapewhen viewed from a coronal plane perspective, and a surface between saidupper and lower ends to limit forward movement of a tongue toward apatient's teeth. FIG. 5B is a view of the retraction device 500 from thetop showing the top frame 504, the bottom frame 506, inlets 512 in thebottom frame, and the tongue retractor 510. FIG. 5C illustrates a sideview of the frame 502, illustrating the top and bottom frames, 504, 506,respectively, and a tongue retractor 510. FIG. 5D illustrates aposterior view of the frame 502, showing the top frame 504, the bottomframe 506, and inlets 512 in the bottom frame 506.

FIGS. 6A-6D illustrate a light ring 614 isolated from the retractiondevice. The lip ring can be used to retract the cheeks, and lips. FIG.6A illustrates a posterior perspective view of the light ring. The lightring 614 can have at least one light source 616, 616′. In someembodiments, the light ring can be a single unit with the lip ring.Alternatively, the light ring can be attached to the lip ring ifnecessary and may have two halves connected by a connector 626. Thelight ring 614 can have at least one opening 625 through which the oralcavity can be illuminated. FIG. 6B is a top view of the light ring 614,showing the light sources 616, 616′. FIG. 6C is a side view of the lipring 614 showing the lip rest 618 and the light source 616. FIG. 6D is aposterior view of the light ring 614. FIG. 6D also shows a lip rest 618,openings 625, 625′ in the lip ring for illuminating the oral cavity, andlight sources 616, 616′.

FIGS. 7A-7D illustrate an alternative embodiment of a retraction device700, wherein the retraction device does not comprise a tongue retractoror gum protection covers. FIG. 7A illustrates a perspective view of aminimalistic retraction device 700 having an anterior end 72 and aposterior end 70 and comprising a frame 702, a lip ring 708 with a lightring 714. FIG. 7B is a top view of the retraction device 700illustrating an upper frame 704 having a first end 705 and a second end705′, a lower frame 706 having a first end 707, a second end 707′ andcomprising at least one inlet 712 for evacuating the oral cavity,wherein respective first ends 705, 707 and second ends 705′, 707′ areconnected via a cross member 740. The device can comprise more than oneinlet. FIG. 7B also illustrates a top view of the lip ring 708 with alight ring 714, lip rest 718, and light sources 716, 716′. FIG. 7C is aside view of the retraction device 700 illustrating the upper frame 704,lower frame 706 with at least one inlet 712, lip ring 708, light ring714 with lip rest 718, and light source 716. FIG. 7D is a posterior viewof the retraction device 700.

FIGS. 8A-8D illustrate an alternative embodiment of a retraction device800 in which the frame is covered by a cover 826. The frame cover 826can be a soft membrane material. The frame cover can be made of anysuitable material including, but not limited to, rubber, or cornpolymers, or “green” or environmentally friendly sustainable materials,or any of the materials previously mentioned. FIG. 8A is a perspectiveview of the device 800 with a cover 826 covering the entire device. Insome embodiments, the cover can cover a portion of the device. The covercan have openings 825 which can fit around the dental surfaces in theoral cavity of the patient. In some embodiments, the opening 825 is aslit. In some embodiments, the opening has a shape similar to the dentalarch. FIG. 8B illustrates a top view of the device 800 showing the cover826 and an opening 825 in the cover 826. FIG. 8C is a side view of thedevice 800. The cover can cover the upper and lower frames of thedevice, with the space between the upper and lower frames remaininguncovered. Alternatively, the cover can cover the space in between theupper and lower frames as shown in FIG. 8C. FIG. 8D is a posterior viewof the device.

FIGS. 9A-9D illustrate a cover 926 isolated from the retraction device.FIGS. 9A-9D show an isolated cover 926 for both the upper and lowerframes.

FIGS. 10A-10D illustrate a light ring 1014 isolated from the retractiondevice. FIG. 10A illustrates a front perspective view of an isolatedlight ring 1014 illustrating the light sources 1016, 1016′ and theoutputs 1015 from the light ring 1014 which can be used to illuminatethe oral cavity. The light ring 1014 can also have a lip rest 1018 asshown in FIG. 10A. FIG. 10B is a top view of the light ring 1014. FIG.10C is a side view of the light ring 1014. FIG. 10D is a posterior viewof the light ring 1014. The outputs 1015 from the light ring 1014 can belocated in the upper part of the light ring, the lower part of the lightring, and on the sides of the light ring, as shown in FIG. 10D.Alternatively, the outputs 1015 from the light ring 1014 can be locatedin only the upper portion of the light ring. The light outputs can belocated only in the lower portion of the light ring. The light outputscan be located in the sides of the light ring. The light outputs can begrouped together or the light outputs can be uniformly spaced throughoutthe light ring. The light outputs can be any suitable output forilluminating the oral cavity including, but not limited to, light bulbs,LEDs, fiber optics, or any combination thereof or any other suitablelight output.

FIGS. 11A-11D illustrate an alternate form of a light ring 1114. In someembodiments, the light ring can be made of a flexible material, as shownin FIGS. 11A-11D. The flexible material allows the light ring to beflexed without damage to the circuit.

FIGS. 12A-12D illustrate an alternate embodiment of an isolated frame ofthe retraction device 1200 having an anterior end 72, a posterior end70, and a cross member 1240. The frame design of the invention canprovide better access to the palette area for scanning, as previouslydescribed. The upper and lower frames also facilitate insertion of ascanning device along the side of the frame. The tissue can be kept awayfrom the teeth so that a powder coating can be applied to the dentalsurfaces. The mouth can be scanned in its entirety without stopping.FIG. 12A is a perspective view of the device as viewed from theposterior side of the device 1200. The lip ring 1208, the upper andlower frames, 1204, 1206 each having first ends 1205, 1205′ and secondends 1207, 1207′, respectively, and tongue retractor 1210 can be seen.FIG. 12B is a top view of the device 1200. FIG. 12C is a side view ofthe device 1200. FIG. 12D is a posterior view of the device 1200.

FIGS. 13A-13D illustrate an alternate embodiment of a retraction device1300 without a tongue retractor and having an anterior end 72, aposterior end 70, and a cross member 1340.

FIGS. 14A-14D illustrate a frame 1402 isolated from a retraction deviceand having an anterior end 72, a posterior end 70, and a cross member1440. The frame can be used alone to retract soft tissue. Alternatively,the frame 1402 can be used with other features or components, such as asoft cover for the frame, a light ring, or lip ring. FIG. 14A isperspective view of the frame 1402. FIG. 14B is a top view of the frame1402. FIG. 14C is a side view of the frame 1402. FIG. 14D is a view ofthe posterior side of the frame 1402.

FIGS. 15A-15D illustrate the frame shown in FIGS. 14A-14D together withan evacuation component. The device 1500 has an anterior end 72 and aposterior end 70. FIG. 15A illustrates the frame 1502 comprising a lipring 1508, and upper frame 1504 having a first end 1505 and a second end1505′ and a lower frame 1506 having a first end 1507 and a second end1507′, wherein respective first ends 1505, 1507 and second ends 1505′,1507′ are connected via a cross-member 1540, wherein the lower frame hasevacuation inlets 1512. FIG. 15B illustrates a top view of the upper andlower frame, 1504, 1506, respectively, the lip ring 1508, and inlets1512 in the bottom frame 1506. FIG. 15C is a side view of the frame 1502of the device 1500 including upper and lower frames 1504, 1506, lip ring1508, and inlets located in the lower frame 1506. FIG. 15D is aposterior view of the retraction device 1500 including upper and lowerframe 1504, 1506, lip ring 1508, and inlets 1512 from the evacuationcomponent of the device.

FIGS. 16A-16D are views of an isolated lip ring. FIG. 16A is aperspective view of the lip ring 1608 from the posterior side of the lipring. The lip ring can have attachment fittings 1609 for attaching thelip ring 1608 to the frame of the retraction device. FIG. 16B is a topview of the lip ring 1608. FIG. 16C is a side view of the lip ring 1608;FIG. 16D is a posterior view of the lip ring 1608.

FIGS. 17A-17 are isolated views of a tongue retractor. The tongueretractor can be a wire structure. Alternatively, the tongue retractorcan comprise a structure that extends into a volume of space forwardfrom the wire structure. The tongue can occupy the space underneath thetongue retractor cover. The tongue retractor can serve to contain andconfine the tongue in a restricted space, thereby preventing the tonguefrom filling the oral cavity. FIG. 17A is a perspective view of a tongueretractor 1710. The tongue retractor 1710 can be a simple structureconsisting of a wire frame. Alternatively, the tongue retractor 1710 cancomprise a cover 1711 for encasing the tongue retractor 1710. The tongueretractor can contain the tongue from at least one side of the tongue.Alternatively, the tongue retractor can contain the tongue from bothsides of the tongue. In some embodiments, the tongue retractor canconfine the tongue in its entirety. The tongue retractor can confine thetongue to a restricted space, thereby preventing the tongue from fillingthe oral cavity. FIG. 17B is a top view of the tongue retractor 1710.FIG. 17C is a side view of a tongue retractor 1710. FIG. 17D is aposterior view of the tongue retractor 1710.

In some embodiments, the retraction device can be of the embodimentsshown in FIGS. 18A-18D. The retraction device 1800 has an anterior end72 and a posterior end 70 and can further comprise a hinge 1828 that canbe used to further alter the shape of the retraction device 1800. Insome embodiments, the hinge can be a flexible material hinge. As shownin FIG. 18A, the retraction device 1800 can comprise an upper frame 1804having a first end 1805 and a second end 1805′, a lower frame 1806having a first end 1807 and a second end 1807′ wherein the respectivefirst ends 1805, 1807 and second ends 1805′, 1807′ are connected via across-member 1840, and a tongue retractor 1810 having an elongatedstructure with an upper end and a lower end when viewed from a sagitalplane perspective, a curved shape when viewed from a coronal planeperspective, and a surface between said upper and lower ends to limitforward movement of a tongue toward a patient's teeth. The upper andlower frames 1804, 1806, respectively can be in mechanical communicationthrough at least one support 1830. The support can comprise a hinge 1828for collapsing the upper frame 1804 toward the lower frame 1806. Thehinge 1828 can facilitate the compression of the device 1800 toundertake a more compact structure for ease in inserting into the oralcavity. In some embodiments, the hinge can be located in the sidesupports. In some embodiments, a hinge can be located in the upper frame1804 or the lower frame 1806 or both the upper and lower frames 1804,1806. The support can be rigidly affixed to the upper and lower frames.Alternatively, the support 1830 can be a swiveling support 1830 as shownin FIG. 18A. FIG. 18B is a top view of the retraction device 1800,illustrating the top frame 1804, the bottom frame 1806, the tongueretractor 1810, and the side supports 1830. FIG. 18C is a side view of aretraction device 1800, illustrating the top frame 1804, the bottomframe 1806, tongue retractor 1810, side support 1830, and hinge 1828.FIG. 18D is a posterior view of the retraction device 1800.

FIGS. 19A-19D show an embodiment of the retraction device 1900 having ananterior end 72, a posterior end 70, a cross member 1940, and a hingeand swivel supports but without a tongue retractor.

Isolated supports 2030, 2030′ are shown in FIGS. 20A-20D. In someembodiments, the supports 2030, 2030′ have at least one hinge 2028,2028′. In some embodiments, the supports comprise multiple hinges. FIG.20A is a perspective view of the isolated supports 2030, 2030′. FIG. 20Bis a top view of the isolated supports 2030, 2030′. FIG. 20C is a sideview of one of the supports 2030 with a hinge 2028. FIG. 20D is aposterior view of two isolated supports 2030, 2030′ and their respectivehinges 2028,2028′.

FIGS. 21A-21D illustrate a lower arch retraction device 2100 having ananterior end 72, a posterior end 70, a lip ring 2108 with light ring2114, and a tongue retractor 2110 having an elongated structure with anupper end and a lower end when viewed from a sagital plane perspective,a curved shape when viewed from a coronal plane perspective, and asurface between said upper and lower ends to limit forward movement of atongue toward a patient's teeth. The tongue retractor is braced betweenthe upper palate and below the tongue area. The lip ring connects to thebottom of the frame. When present, an evacuation component is thenpositioned over the top of the lip ring to form a single unit. The lipring 2118 is held in place by the upper lip in conjunction with the liprest 2118 and the lower soft tissue anatomy surrounding the area. Thedevice can have a frame covered with a soft membrane cover as shown inFIG. 21A. In some embodiments, suction can be administered to the oralcavity through inlets 2112 in the soft membrane. FIG. 21B is a top viewof the retraction device 2100, illustrating the lower frame 2106 havinga first end 2107 and a second end 2107′, wherein first end 2107 andsecond end 2107′ are connected via a cross member 2140, with lower gumprotection cover 2122, inlets in the lower frame 2106 and lower gumprotection cover 2122, and lip ring 2108 with light ring 2114 and lightsources 2116, 2116′. FIG. 21C is a side view of the retraction device2100. FIG. 21D is a posterior view of the retraction device 2100.

FIGS. 22A-22D illustrate an alternative embodiment of a retractiondevice 2200 having an anterior end 72 and a posterior end 70 andcomprising a frame 2206 with gum protector 2222 without a lip ring. FIG.22A is a perspective view of a retraction device 2200. FIG. 22B is a topview of a retraction device 2200 illustrating a lower frame 2206 havinga first end 2207 and a second end 2207′ wherein first end 2207 andsecond end 2207′ are connected via a crossmember 2240, with gumprotector 2222 with inlets 2212 along the lower frame 2206, and tongueretractor 2210 having an elongated structure with an upper end and alower end when viewed from a sagital plane perspective, a curved shapewhen viewed from a coronal plane perspective, and a surface between saidupper and lower ends to limit forward movement of a tongue toward apatient's teeth. FIG. 22C is a side view of the retraction device 2200.FIG. 22D is a posterior view of the retraction device 2200.

FIGS. 23A-23D illustrate a tongue retractor membrane or cover 2311configuration. The device has an anterior end 72, a posterior end 70,and at least one cross-member 2340. FIG. 23A illustrates a perspectiveview of the tongue retractor 2310 as viewed from the posterior side ofthe device. FIG. 23B illustrates a top view of the tongue retractor 2311with cover 2311. FIG. 23C illustrates a side view of the tongueretractor 2310 having an elongated structure with an upper end and alower end when viewed from a sagital plane perspective, a curved shapewhen viewed from a coronal plane perspective, and a surface between saidupper and lower ends to limit forward movement of a tongue toward apatient's teeth. FIG. 23D is a posterior view of the tongue retractorcover 2310.

FIGS. 24A-24D illustrate a view of an isolated lower frame 2406 from alower arch retraction device. The device has an anterior end 72, aposterior end 70, and at least one cross-member 2440. In someembodiments, the lower frame comprises at least one inlet 2412 forevacuating the oral cavity. FIG. 24A illustrates a perspective view ofthe frame 2406. FIG. 24B is a top view of the lower frame 2406 having afirst end 2407 and a second end 2407′. FIG. 24C is a side view of theframe 2406. FIG. 24D is a posterior view of the frame 2406.

FIGS. 25A-25D illustrate an alternative embodiment of a lower frameretraction device 2500. The device shown in FIGS. 25A-25D illustrate adevice that has leverage once positioned in the mouth to hole the bottomarch in position, thereby preventing the tongue from lifting the bottomarch out of position. The device has an anterior end 72, a posterior end70, and at least one cross-member 2540. FIG. 25A is a perspective viewof the lower frame retraction device 2500. The retraction device 2500shown in FIG. 25A does not rely upon the upper palette and the tongueretractor 2510 to stabilize the device 2500. Therefore, the device isless intrusive than other devices and can further facilitate scanningthe oral cavity. FIG. 25A also illustrates a device 2500 having a lowerframe 2506 with gum protection cover 2522 with an opening 2525 for thedental arch. The device can also have a lip ring 2508 with a light ring2514 having lights 2516, 2516′ thereon and lip rest 2518. FIG. 25Billustrates a top view of the device 2500. FIG. 25C illustrates a sideview of the device 2500. FIG. 25D illustrates a posterior view of thedevice 2500.

An alternate embodiment of a lower arch retraction device 2600 is shownin FIGS. 26A-26D. The device has an anterior end 72, a posterior end 70,and at least one cross-member 2640. FIG. 26A illustrates a lower frame2606, having a first end 2607 and a second end 2607′, with a gum cover2622, and a tongue retractor 2610. An opening 2625 for the dental archis shown in FIG. 26A. Furthermore, a suction port 2624 can connect theretraction device 2600 to a source of suction to evacuate the oralcavity through at least one inlet 2612 located in the frame or gumprotector or both. FIG. 26B is a top view of the retraction deviceshowing the suction port 2624 and inlets 2612 in communication,preferably fluid communication, with the suction port 2624, the lowerframe 2606 and gum protection cover 2622, tongue retractor 2610, and theopening 2625 for the dental arch in the retraction device 2600. FIG. 26Cis a side view of a retraction device 2600 illustrating the frame 2606,the gum protection cover 2622, the tongue retractor 2610, and suctionport 2624. FIG. 26D is a posterior view of the retraction device 2600.

FIGS. 27A-27D illustrate an alternate embodiment of an isolated lowerarch retraction device 2700. The device has an anterior end 72 and aposterior end 70. FIG. 27A illustrates a retraction device 2700comprising an alternate embodiment of a lip ring 2708, an upper frame2704 having a first end 2705 and a second end 2705′, a lower frame 2706having a first end 2707 and a second end 2707′ wherein respective firstends 2705, 2707 and second ends 2705′, 2707′ are connected via across-member 2740, and a tongue retractor 2710 having an elongatedstructure with an upper end and a lower end when viewed from a sagitalplane perspective, a curved shape when viewed from a coronal planeperspective, and a surface between said upper and lower ends to limitforward movement of a tongue toward a patient's teeth. The retractiondevice 2700 also has a posterior balancing positional support 2732 whichaids in the insertion of the device into the oral cavity and providesposterior balancing positional support. The posterior balancingpositional supports 2732 contact the back of the cheeks to balanceforces from the front of the cheeks in order to properly center thedevice along the posterior/anterior axis. FIG. 27B is a top view of theretraction device 2700 illustrating the lip ring, 2708, lower frame2706, tongue retractor 2710, and posterior supports 2732. FIG. 27C is aside view of the retraction device, showing the lip ring 2708, lowerframe 2706, tongue retractor 2710, and posterior supports 2732. FIG. 27Dis a frontal view of the retraction device 2700 illustrating the lipring 2708, lower arch frame 2706, tongue retractor 2710, and posteriorsupports 2732.

FIGS. 28A-28D illustrate an isolated evacuation element 2834. The devicehas an anterior end 72, a posterior end 70, and at least onecross-member 2840. FIG. 28A is a perspective view of an evacuationelement 2834 as viewed from the posterior side. The evacuation elementcan be in communication with a suction source through the suction port2824. The evacuation element 2834 can be used to evacuate the oralcavity through at least one inlet 2812 located in the evacuation element2834. In some embodiments, multiple evacuation elements 2812 can belocated along the length of the evacuation element, as shown in FIG.28A. In some embodiments, inlets 2812 can be located along the interiorof the cheeks. In some embodiments, inlets 2812 can be located aroundthe tongue. Inlets 2812 can be located along both the cheeks and thetongue. FIG. 28B is a top view of the evacuation element. FIG. 28C is aside view of the evacuation element 2834. FIG. 28D is a posterior viewof the evacuation element 2834.

FIGS. 29A-29D illustrate an isolated tongue deflection cover 2911. Thedevice has an anterior end 72, a posterior end 70, and at least onecross-member 2940. The tongue deflection cover can be used to deflectthe tongue out of the working space to facilitate scanning the dentalsurfaces. FIG. 29A illustrates a perspective view of the tonguedeflection cover 2911 as viewed from the posterior side. FIG. 29Billustrates a top view of the tongue deflection cover 2911. FIG. 29Cillustrates a side view of a tongue deflection cover. FIG. 29Dillustrates a posterior view of the tongue deflection cover.

FIGS. 30A-30D illustrate an isolated upper arch frame 3004. The devicehas an anterior end 72, a posterior end 70, and at least onecross-member 3040. The upper arch frame 3004 can be used in conjunctionwith a lower arch retraction device. The upper arch frame 3004 can beused to provide optional support for upper retraction of the soft tissuein the oral cavity. FIG. 30A illustrates one embodiment of an upper archframe 3004. The arch support can comprise connectors 3036 to connect theupper arch frame 3004 to the retraction device. The upper arch frame3004 can be connected to the lower retraction device by snapping theupper arch frame 3004 and the lower retraction device together.Alternatively, the upper arch frame 3004 can connected to the lowerretraction device by screwing the pieces together. Alternatively, theupper arch frame can be adhered to the lower retraction device by anysuitable adhesive or mechanism for adhering the two units togetherincluding but not limited to, glue, tape, rubber bands, or anycombination thereof. FIG. 30B is a top view of an isolated upper archframe 3004. FIG. 30C is a side view of an upper arch frame. FIG. 30D isa posterior view of an upper arch frame.

FIGS. 31A-31D illustrate an alternative embodiments of an isolated upperarch retraction device 3100 including a lower arch frame 3108. Thedevice has an anterior end 72, a posterior end 70, and at least onecross-member 3140, which includes a first lateral extension 3140A and asecond lateral extension 3140B. In some embodiments, the retractiondevice is a single piece. In some embodiments, the retraction device3100 can be more than one piece, where the pieces are assembled prior toinserting the device into the oral cavity. The lip ring can be attachedto the frame at the posterior end of the device 3100. FIG. 31A is aperspective view of upper arch retraction device 3100 having a lowerarch frame 3108, an upper arch frame 3104, and a tongue retractor 3110attached to the first and the second lateral extension 3140A and 3140Band having an elongated structure with an upper end and a lower end whenviewed from a sagital plane perspective, a curved shape when viewed froma coronal plane perspective, and a surface between said upper and lowerends to limit forward movement of a tongue toward a patient's teeth. Insome embodiments, the device 3100 further comprises a tongue cover forcontaining the tongue. FIG. 31B is a top view of the retraction device3100, illustrating the upper arch frame 3104, the lower arch frame 3108,the first and the second lateral extension 3140A and 3140B, and tongueretractor 3110. FIG. 31C is a side view of the retraction device 3100.FIG. 31D is a frontal view of the retraction device 3100.

FIGS. 32A-32D illustrate an alternative embodiment of a retractiondevice 3200. The device has an anterior end 72, a posterior end 70, andat least one cross-member 3240. In this embodiment, the upper retractionframe 3204 has a first end 3205 and a second end 3205′ and is separatedby a gap 3238. In some embodiments, the lower arch frame 3208 can have agap 3238. In some embodiments, both the upper frame 3204 and the lowerarch frame 3208 have a gap 3238, as shown in FIG. 32A. The device canhave a tongue retractor 3210 having an elongated structure with an upperend and a lower end when viewed from a sagital plane perspective, acurved shape when viewed from a coronal plane perspective, and a surfacebetween said upper and lower ends to limit forward movement of a tonguetoward a patient's teeth. FIG. 32B is a top view of a retraction device3200 with a gap 3238. FIG. 32C illustrates a side view of a retractiondevice 3200. FIG. 32D illustrates a front view of the retraction device3200.

II. Methods

Further provided herein are methods of use of the invention describedherein. Provided herein is a method of retracting tissue in an oralcavity comprising: inserting a retraction device comprising a topologyconformable structure adaptable to be in a constrained shape that can bedelivered into an oral cavity and further adaptable to be in anunconstrained shape to create a useable working field in the oralcavity, the useable working field providing increased accessibility toand increased visibility within the oral cavity; and positioning theretraction device in the oral cavity to create an isolated workingfield. The positioning step can be performed in less than 1 minute. Insome embodiments, the positioning step can be performed in less than 20seconds.

Yet another method for retracting tissue in an oral cavity comprises:inserting a retraction device comprising a topology conformablestructure adaptable to create a working field in an oral cavity of apatient, wherein the working field is at least 10% larger than a workingfield in oral cavity of the patient without use of the device; andpositioning the retraction device in the oral cavity to create anisolated working field.

Another method provided herein is a method of facilitating the creationof an oral cavity model comprising: inserting a retraction devicecomprising a topology conformable structure adaptable to be in aconstrained shape that can be delivered into an oral cavity and furtheradaptable to be in an unconstrained shape to create a useable workingfield in the oral cavity, the usable working field providing increasedaccessibility to and increased visibility within the oral cavity; andpositioning the retraction device in the oral cavity to create theuseable working field in the oral cavity. In some embodiments, themethod can further comprise the step of illuminating the oral cavitywith the retraction device. Additionally, the method can comprise thestep of applying a powder to the at least one dry tooth surface.

III. Materials Of Manufacture

As will be appreciated by those skilled in the art, the devicesdescribed herein, and other device designs that can be employed underthe invention based on the teachings herein, and their components can bemade from a variety of materials known in the art. Candidate materialsfor the devices and components would be known by persons skilled in theart and include, for example, the materials described above as well assuitable biocompatible materials such as metals (e.g. stainless steel,shape memory alloys, such a nickel titanium alloy nitinol) andengineering plastics (e.g. polycarbonate). See, for example U.S. Pat.No. 5,190,546 to Jervis for Medical Devices Incorporating SIM MemoryAlloy Elements and U.S. Pat. No. 5,964,770 to Flomenblit for HighStrength Medical Devices of Shape Memory Alloy. For example, a deviceframe may be made of materials such as titanium, cobalt chrome stainlesssteel. Alternatively, a sheath or outer layer covering a frame can bemade of biocompatible polymers such as polyetheretherketone (PEEK),polyarylamide, polyethylene, and polysulphone. See, for example U.S.Pat. No. 5,190,546 to Jervis for Medical Devices Incorporating SIMMemory Alloy Elements and U.S. Pat. No. 5,964,770 to Flomenblit for HighStrength Medical Devices of Shape Memory Alloy. Other materials may beappropriate for some or all of the components, such as biocompatiblepolymers, including polyetheretherketone (PEEK), polyarylamide,polyethylene, and polysulphone. U.S. Pat. No. 5,964,770 to Flomenblitfor High Strength Medical Devices of Shape Memory Alloy.

A variety of hydrophillic materials, hydrophobic materials, or puttiescan also be used, e.g. to form seals. Such materials would be known to aperson skilled in the art and include, for example, hydrophilic materialor a putty (e.g., Van-R reversible hydrocolloid, available from DuxDental, and vinyl polysiloxane, available from 3M Express), as discussedabove. Other materials that might also be used include, for example,poly(vinyl alcohol) (PVA) hydrogels, hydrophillic, medical grade foam,polysaccharides, glucosaminoglycans. Additional materials can include,silicons, thermal plastic elastiomers (TPE), thermal plastic urethanes(TPU), nylons and material, epoxys, corn polymers or otherenvironmentally friendly materials, or any combination thereof. Thematerial can also be any suitable biocompatible material.

In some embodiments, the device can be constructed from materials havingdifferent properties. In some embodiments, the devices described hereincan be created from single property membrane transformed into multipleproperties. The material can harden through additional processes, suchas by changing the molecular structure of the material. In someembodiments, the material can be placed over a frame or device. Thematerial can then undergo a process that can change the materialproperties of the material. In some embodiments the material property ofthe device is the same throughout. Alternatively, the device can becomprised of material having different properties. For example, thematerial of the device can be harder or stiffer in some areas and softerin other areas. The properties of the material can be changed using alaser. Alternatively, the properties of the material can be changedusing light. The properties of the material can be changed using anysuitable method for altering the material characteristics of thematerial including, but not limited to, temperature and pH, lasercuring, stereolithographic laser polymerization and crosslinking,optical post manufacturing processing, and chemical post manufacturingprocessing, or any combination thereof.

IV. Kits

The invention also contemplates a kit comprising one or more deviceswith one or more device products associated with a particular dentaltreatment. For example, lasers are currently used in dentistry forvarious applications including but not limited to: cavity removal,cutting or hardening bonding material, whitening teeth, andre-contouring, reshaping, or removing gum tissue. The device herein canbe used in combination with laser therapy to act as a shield and tongueand cheek retractor, preventing other regions of the mouth from beingaffected by the laser. Thus compounds used with the laser procedurecould be provided in the kit with the devices or devices, as well asequipment adaptors, etc.

Additionally, a kit comprising one or more devices with one or morecomplementary automatic impression tray system(s) or implant specificimpression tray(s), which are designed to fit over the upper and/orlower arches of teeth, to capture a detailed and accurate impression ofeach full arch of teeth and the surrounding alveolar process andgingiva, which the device is in place. This prevents any contaminationof the impression(s) with saliva and prevents any escape of impressionmaterials into the mouth cavity or the patient's throat.

Further provided herein are kits for retracting tissue in an oralcavity. Provided herein are kits for retracting tissue in an oral cavitycomprising: a topology conformable structure adaptable to be in aconstrained shape that can be delivered into an oral cavity and furtheradaptable to be in an unconstrained shape to create a useable workingfield in the oral cavity, the useable working field providing increasedaccessibility to and increased visibility within the oral cavity. Insome embodiments, the kit can further comprise a tongue retractor.Additionally, the kit can further comprise a light ring. Furthermore,the kit can comprise an evacuation component. The kit can furthercomprise a membrane adaptable to be fitted over the frame. In someembodiments, the kit can further comprise a gum protection cover. Thekit can also further comprise a lip ring.

Furthermore, additionally provided herein is a kit for retracting tissuein an oral cavity comprising: a retraction device comprising a topologyconformable structure adaptable to be in a constrained shape that can bedelivered into an oral cavity and further adaptable to be in anunconstrained shape to create a useable working field in the oralcavity, the useable working field providing increased accessibility toand increased visibility within the oral cavity; and a kit of secondarydental products wherein tissue retraction in the oral cavity isnecessary. In some embodiments, the kit can further comprise anillumination source. Additionally, the kit can comprise at least oneoptical scanner or digital scanner. Furthermore, the kit can furthercomprise a powder for facilitate scanning of the dental surfaces. Insome embodiments, the kit can further comprise a whitening or bleachingkit.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A soft tissue retraction device comprising: aright posterior end; a left posterior end positioned opposite the rightposterior end; an upper frame having an upper anterior end, the upperframe extending from the upper anterior end to the right posterior endand to the left posterior end; a lower frame that is interconnected withthe upper frame at the right posterior end and the left posterior end,the lower frame having a lower anterior end and extending from the loweranterior end to the right posterior end and to the left posterior end; across member including: a first lateral extension interconnected withthe lower frame and the upper frame at the left posterior end, and asecond lateral extension interconnected with the lower frame and theupper frame at the right posterior end; and a tongue retractor attachedto the first lateral extension and the second lateral extension, whereineach of the first lateral extension and the second lateral extension isposteriorly curved between the left posterior end and right posteriorend.
 2. The soft tissue retraction device of claim 1, wherein the upperframe and the lower frame generally coincide with an arch shape.
 3. Thesoft tissue retraction device of claim 2, wherein: the upper frame ispositionable around an outer surface of an upper dental arch; and thelower frame is positionable around an outer surface of a lower dentalarch.
 4. The soft tissue retraction device of claim 1, furthercomprising a lip rest that extends from the upper anterior end andconfigured to protrude an upper lip away from teeth of an upper dentalarch of a patient.
 5. The soft tissue retraction device of claim 1,wherein the upper frame and the lower frame include two or more radii ofcurvature between the right posterior end and the left posterior end. 6.The soft tissue retraction device of claim 1, wherein: the upper frame,the lower frame, the cross member, and the tongue retractor is a singlepiece; and the upper frame, the lower frame, the cross member, and thetongue retractor are comprised of a plastic material.
 7. The soft tissueretraction device of claim 1, wherein: the upper frame and the lowerframe are configurable in a constrained shape and in an unconstrainedshape; in the unconstrained shape, the upper anterior end of the upperframe and lower anterior end of the lower frame are positioned a firstdistance from one another; in the constrained shape, the upper anteriorend of the upper frame and lower anterior end of the lower frame are asecond distance from one another, the second distance being less thanthe first distance; in the unconstrained shape, the upper frame and thelower frame create an working field in a mouth of a patient around teethof the patient; and in the constrained shape, the upper frame and thelower frame are inwardly collapsed to narrow a height between the upperanterior end and the lower anterior end to facilitate insertion into amouth of the patient.
 8. The soft tissue retraction device of claim 7,wherein the upper frame and the lower frame are sized and configured toreside substantially entirely within the mouth when configured in theunconstrained shape.
 9. The soft tissue retraction device of claim 1,wherein: the tongue retractor is configured to limit movement of atongue of a patient; and the tongue retractor includes a membrane thatextends toward the upper anterior end to create a space configured toreceive the tongue.
 10. The soft tissue retraction device of claim 1,wherein: the tongue retractor comprises a polymer structure and amembrane connected to the polymer structure; and the membrane isconfigured to deflect a tongue from a working space.
 11. The soft tissueretraction device of claim 1, wherein each of the first lateralextension and the second lateral extension is posteriorly curved toextend posteriorly behind the left posterior end and the right posteriorend.
 12. The soft tissue retraction device of claim 11, wherein each ofthe first lateral extension and the second lateral extension areconfigured to extend posteriorly behind posterior teeth in a mouth andconfigured to permit engagement of occlusal tooth surfaces of theposterior teeth.
 13. A soft tissue retraction device configured tocreate a working field in a mouth of a patient, the soft tissueretraction device comprising: a right posterior end; a left posteriorend opposite the right posterior end; a lower frame including ananterior end, the lower frame extending from the anterior end to theright posterior end and to the left posterior end; a tongue retractorconfigured to limit movement of a tongue of the patient; and a crossmember including: a first lateral extension interconnected with thelower frame at the left posterior end and with the tongue retractor, thefirst lateral extension extending towards the right posterior end andbeing posteriorly curved between the left posterior end and the tongueretractor to extend posterior to the left posterior end; and a secondlateral extension interconnected with the lower frame at the rightposterior end and with the tongue retractor, the second lateralextension extending towards the left posterior end and being posteriorlycurved between the right posterior end.
 14. The soft tissue retractiondevice of claim 13, further comprising an upper frame having an upperanterior end, wherein: the upper frame extends from the upper anteriorend to the right posterior end and to the left posterior end; and thelower frame is interconnected with the upper frame at the rightposterior end and the left posterior end.
 15. The soft tissue retractiondevice of claim 14, wherein: the upper frame and the lower framegenerally coincide with an arch shape; an upper frame is positionablearound an outer surface of an upper dental arch; and a lower frame ispositionable around an outer surface of a lower dental arch.
 16. Thesoft tissue retraction device of claim 15, wherein the upper frame andthe lower frame include two or more radii of curvature between the rightposterior end and the left posterior end.
 17. The soft tissue retractiondevice of claim 13, wherein: the tongue retractor comprises elongatedstructure with an upper end, a lower end, and a membrane; the upper endand the lower end are comprised of a polymer structure; the membrane isconnected to the polymer structure; and the membrane is configured todeflect the tongue from a working field.
 18. The soft tissue retractiondevice of claim 13, wherein each of the first lateral extension and thesecond lateral extension are configured to extend posteriorly behindposterior teeth in the mouth and configured to permit engagement ofocclusal tooth surfaces of the posterior teeth.
 19. A soft tissueretraction device comprising: a lower arch frame including a loweranterior end, the lower arch frame extending from the lower anterior endto a right posterior end and from the lower anterior end to a leftposterior end, and the lower arch frame including two or more radii ofcurvature between the right posterior end and the left posterior end; anupper arch frame interconnected with the lower arch frame, the upperarch frame including an upper anterior end, extending from the upperanterior end to the right posterior end and from the upper anterior endto the left posterior end, and including two or more radii of curvaturebetween the right posterior end and the left posterior end; a tongueretractor including a polymer structure and a membrane connected to thepolymer structure, the membrane being configured to deflect a tonguefrom a working field; a first lateral extension interconnected with thelower arch frame, the upper arch frame, and the tongue retractor, thefirst lateral extension extending towards the right posterior end andbeing posteriorly curved between the left posterior end and the tongueretractor to extend posterior to the left posterior end; and a secondlateral extension interconnected with the lower arch frame, the upperarch frame, and the tongue retractor, the second lateral extensionextending towards the left posterior end and being posteriorly curvedbetween the right posterior end and the tongue retractor to extendposterior to the right posterior end.
 20. The soft tissue retractiondevice of claim 19, wherein: the upper arch frame and the lower archframe are configurable in a constrained shape and in an unconstrainedshape; in the constrained shape: the upper anterior end and loweranterior end are a first distance from one another, and the upper archframe and the lower arch frame are inwardly collapsed to narrow a heightbetween the upper anterior end and the lower anterior end to facilitateinsertion into a mouth of a patient; in the unconstrained shape: theupper anterior end and lower anterior end are positioned a seconddistance from one another, the second distance being greater than thefirst distance; the upper frame is positionable around an outer surfaceof an upper dental arch; the lower frame is positionable around an outersurface of a lower dental arch; and the first and second lateralextensions are positionable behind posterior teeth in the mouth.